Introduction
India has established itself as a global hub for pharmaceutical research, often referred to as “the pharmacy of the world.” This status was redefined in 2005 when India aligned its intellectual property (IP) regime with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The Patents (Amendment) Act of 2005 introduced full patent protection for pharmaceutical products, which, along with regulatory reforms, has encouraged significant investments in clinical trials.
Intellectual property plays a pivotal role in fostering innovation and enabling the development of new drugs. Clinical trials are integral to this process and play a dual role in generating critical data for regulatory approvals and influencing patentability decisions. India’s unique patent framework—particularly Sections 2(1)(j) and 3(d) of the Patents Act—requires careful navigation to balance innovation incentives with public welfare.
This article explores the relationship between clinical trials and patentability, examining key legal provisions, landmark cases, and practical strategies for overcoming objections.
Inventiveness and Clinical Trial Data
An invention is defined under Section 2(1)(j) of the Patents Act as a product or process involving an inventive step and industrial applicability. Section 2(1)(ja) elaborates that an inventive step involves technical advancement, economic significance, or both, rendering the invention non-obvious to a person skilled in the art.
The Role of Clinical Trials: Clinical trial data can be instrumental in addressing objections related to inventive step during patent prosecution. By providing empirical evidence of how a new formulation addresses limitations in the prior art, applicants can demonstrate inventive step.
Illustrative Case: A medicament was prepared with composition A. Medicament B is known in the prior art for the same indication. Both medicaments differ from each other by way of the ratio of the components in the composition. It has already been established that the medication B has been stable for 1 year. However, when the clinical trial is done for medicament A, the stability is 2 years without any side effect or decline in therapeutic efficacy. Therefore, the technical problem of the prior art, i.e., short stability time, is overcome by the composition of the medicament A. Thus, to assess the inventive step of the medicament, the clinical trial establishing the efficacy of treatment with medicament and reasonable expectation of success will be helpful for the client to overcome the objection.
Using Clinical Data to Contest Non-Patentability under Section 3(d)
Section 3(d) of the Patents Act excludes the mere discovery of a new form, property, or use of a known substance unless it results in enhanced efficacy. The explanation to Section 3(d) specifies that salts, esters, ethers, polymorphs, and other derivatives of a known substance are considered the same substance unless they show significant efficacy improvements.
This provision aims to prevent evergreening by requiring a demonstrable improvement in therapeutic efficacy for patentability.
To overcome Section 3(d) objections, applicants must demonstrate significant improvements in therapeutic efficacy through clinical or experimental data.
Several landmark judgments have clarified the role of clinical trial data in patentability:
Novartis AG v. Union of India1
Novartis sought a patent for the beta crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukemia. Novartis argued its beta-crystalline form had better bioavailability than imatinib’s freebase form. Novartis also conducted studies to compare the properties of the two forms and submitted the results in the form of affidavits during the prosecution. The Indian Patent Office rejected the application under Section 3(d), stating that the new form did not show enhanced therapeutic efficacy. The case went all the way to the Supreme Court on appeal, where the Court considered the additional data but finally ruled that improved bioavailability alone does not satisfy the efficacy requirement under Section 3(d). To qualify for patentability, the applicant must demonstrate that the new form provides significant therapeutic advantages over the known form.
Therefore, it is well-established by the Supreme Court of India that additional data or lab experiments submitted to support the patent application throughout the application’s prosecution must be taken into account.
Ischemix LLC v. Controller of Patents2
Building on the principles set in Novartis, the Ischemix case explores the admissibility of clinical trial data during prosecution, particularly when addressing objections under Section 3(d).
Ischemix applied for a patent focused on a specific isomer of a known compound and claimed to demonstrate improved therapeutic properties for treating ischemia. During prosecution, objections under Section 3(d) were raised on the grounds that the claimed compound was a new form of a known substance and that the applicant failed to demonstrate enhanced therapeutic efficacy. In response, Ischemix submitted clinical trial data, in vitro, and in vivo studies to substantiate the claim of improved efficacy. However, the Patent Office rejected the application, stating that the submitted data was insufficient to establish a significant enhancement in therapeutic efficacy.
On appeal, the Delhi High Court held that clinical trial data could be submitted during prosecution. However, such data can only be used to support claims already disclosed in the specification. The data cannot introduce entirely new claims or concepts. The court noted that while Ischemix had included comparative data in the specification, they had not adequately explained how the data demonstrated enhanced therapeutic efficacy. It stressed the need for precise explanations and alignment of submitted data with the claims in the patent specification.
Recognizing the iterative nature of drug development, the court remanded the matter to the Patent Office, allowing Ischemix to submit additional clinical trial data to substantiate their claims. It was further held that there is no specific time bar in the Patents Act preventing applicants from submitting additional documents during prosecution.
Oyster Point Pharma Inc vs The Controller of Patents3
Oyster Point Pharma sought a patent for a pharmaceutical compound but faced objections under Section 3(d) due to a lack of data demonstrating enhanced efficacy. The applicant submitted comparative studies and clinical trial data during prosecution to establish efficacy improvements, however, the application was refused under Section 3(d).
On appeal, the court recognized that drug development is an iterative process, and applicants may not have complete data at the time of filing. The court permitted the submission of additional data during prosecution and directed the Patent Office to consider these supplementary documents.
Practical Strategies for Applicants
To effectively navigate objections under Sections 2(1)(j) and 3(d), applicants should adopt the following approaches:
- Submit Additional Clinical Data – Applicants may submit additional clinical trial data in the form of an affidavit later during the prosecution of patent applications in the Indian Patent Office to further establish patentability.
- Align Clinical Data with Disclosure: However, ensure that the clinical trial data support the invention’s claims and are consistent with the original patent specification. Misalignment may lead to rejections or legal challenges.
- Submit Additional Data Strategically: When complete data sets are unavailable at the time of filing, additional data can be submitted during prosecution. Indian courts have recognized the iterative nature of drug development and permitted supplementary data to address objections.
- Engage with Controllers: If the technical advancement is achieved and the technical problem (such as stability of the drug, retention time, etc) of the prior art is solved by a change in the pharmaceutical composition, then the applicant may establish that the pharmaceutical invention is non-obvious to a person skilled in the art using the data of the clinical trials.
Conclusion
India’s unique patent framework requires applicants to balance robust IP protections with compliance with public interest safeguards. Clinical trials serve as a cornerstone for demonstrating both inventive step and enhanced efficacy, particularly under Sections 2(1)(j) and 3(d) of the Patents Act. Judicial interpretations underscore the importance of aligning clinical trial data with patent specifications and addressing objections proactively.
By strategically using clinical trial data and aligning disclosures with patent claims, applicants can navigate India’s patent system effectively. This approach not only strengthens the case for patentability but also contributes to the larger goal of fostering innovation while ensuring access to affordable medicines.